This invention pertains to a device for storing and retaining a natural tissue heart valve, and, more particularly, to a device for retaining a natural tissue heart valve mounted on a valve stent and ready for implantation.
Heart valves taken from pigs and suitably processed are used for implantation in human patients. These heart valves are mounted on a cloth covered framework known as a stent which includes a cylindrical base with three projecting commissure support struts to hold the margins of the cusps of the heart valve. From the base of the stent includes an exterior a sewing ring for suturing into the annulus of the patient when installing the porcine valve in place of the removed diseased valve.
Prior to implantation, the heart valve is treated with a glutaraldehyde solution to preserve the tissue. After mounting in the stent, the valve is stored in a jar or other container of glutaraldehyde solution until such time as the valve is needed for implantation. To protect the valve during storage, it is generally immobilized by means of a packing of rayon or other fibrous material which may include rayon balls inserted into the cusps of the heart valve, frequently with a gauze wrapping around the valve. When the valve is to be used, it is necessary to remove this packing material and to rinse the valve to remove the glutaraldehyde solution. Despite thorough rinsing and washing there is a possibility that some fiber of the packing may be retained on the valve. The presence of fibers or other foreign materials on the valve at the time of implantation can result in clotting and present a danger to the patient.
It is accordingly an object of the present invention to provide a valve holder and retaining device which assures the safe storage and transportation of the tissue heart valve. It is a further object to provide a storage device in which the valve is protected from foreign material. It is a yet further object of this invention to provide a valve holder and storage device which allows the valve to be rinsed and prepared for implantation with a minimum of handling or manipulation. These and other objects of this invention will be readily apparent from the following description.